PAS in Subacute SCI

March 1, 2024 updated by: Anastasia Shulga, Helsinki University Central Hospital

Paired Associative Stimulation in Subacute Spinal Cord Injury

The investigators have recently shown in incomplete SCI patients that long-term paired associative stimulation is capable of restoring voluntary control over some paralyzed muscles and enhancing motor output in the weak muscles. In this study, the investigators will administer long-term paired associative stimulation to patients with incomplete cervical level SCI at the subacute stage, and investigate its effectiveness for upper extremity rehabilitation.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00029
        • BioMag laboratory, Helsinki University Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. SCI caused by an external trauma or SCI caused by nontraumatic non-progressive disease of the spinal cord
  2. Cervical level injury, tetraplegia
  3. Time from injury/onset of symptoms 1-4 months
  4. Medical condition stable
  5. Residual neural connectivity in upper extremity: some voluntary activity in finger muscles or MEPs obtainable from distal hand muscles

Exclusion Criteria:

  1. Diagnosed brain damage, visible in MRI or CT.
  2. No activity in hands/fingers and no MEPs recorded from distal hand muscles.
  3. Epilepsy
  4. Metal inclusion in the head area
  5. High intracranial pressure
  6. Pacemaker
  7. Implanted hearing device
  8. Progressive diseases of spinal cord or brain (e.g. malignant tumors, degenerative diseases).
  9. History of malignant tumor within the past 5 years.
  10. Previous head or spinal cord injury affecting the motor performance of upper extremities.
  11. Congenital anomaly in the anatomical structure of spinal canal/cord or dura.
  12. Significant systemic disease or other condition that could cause neurological deficit, or may affect subject's capability to undergo investigation-related procedures.
  13. Acute severe infection.
  14. Contraindications for MRI.
  15. Current severe psychiatric diseases.
  16. Current chronic drug and/or alcohol abuse.
  17. Pregnancy.
  18. Severe emergency care polyneuropathy
  19. Pressure ulcer affecting the subject's capability to undergo the procedure safely

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham
Device: Sham paired associative stimulation
Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.
Experimental: Paired Associative Stimulation
Device: Paired associative stimulation
Paired associative stimulation (PAS) administered several times per week for 12 weeks to upper limbs. PAS comprises transcranial magnetic stimulation (eXimia magnetic stimulator, Nexstim Ltd, Helsinki, Finland) and peripheral nerve stimulation (given with Dantec Keypoint® electroneuromyography device (Natus Medical Incorporated, Pleasanton, CA, USA)).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daniels and Worthingham's Muscle Testing
Time Frame: Change from baseline score immediately after, 6 months after and 1 year after last stimulation session
hand muscle strength is evaluated on 0-5 scale (0=no movement, 5=normal)
Change from baseline score immediately after, 6 months after and 1 year after last stimulation session
Spinal Cord Independence Measure (SCIM)
Time Frame: Change from baseline score immediately after, 6 months after and 1 year after last stimulation session
standard SCIM evaluation
Change from baseline score immediately after, 6 months after and 1 year after last stimulation session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2019

Primary Completion (Estimated)

May 10, 2024

Study Completion (Estimated)

December 10, 2024

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

September 23, 2019

First Posted (Actual)

September 24, 2019

Study Record Updates

Last Update Posted (Actual)

March 4, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WFL-FI-15/19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spinal Cord Diseases

Clinical Trials on Paired associative stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe